足と足首の臨床研究

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A Multi-Center Pilot Study to Evaluate the Efficacy and Safety of NonDimethyl Sulfoxide (Non-Dmso) Viable Umbilical Cord Graft on Diabetic Foot Ulcers

Robert Fridman*, Chengcheng Tu and Joseph Larson

Diabetic Foot Ulcers (DFUs) are one of the main reasons for diabetes-related hospitalizations, all the while creating an economic burden on the healthcare system and considerably impairing quality of life. In cases where a wound fails to decrease in size by 50% within 4 weeks with standard-of-care, it may be appropriate to initiate advanced levels of care to attempt to close the wound and limit complications. Use of amnion/chorion-based skin substitutes that have been cryopreserved and contain viable cells have been shown to achieve full wound closure with less treatments and in less time. Currently, the standard for cryopreservation of mesenchymal stem cells (MSCs) is done with dimethyl sulfoxide (DMSO), which is easily permeable and able to protect MSCs from cryo-injuries. However, DMSO has been shown to have deleterious effects on the viability of cells and tissue, and has adverse effects in humans. Therefore, there is a growing effort to develop DMSO-free cryoprotectants. This pilot study is being presented to study the effects and safety of non-dimethyl sulfoxide (NonDMSO) viable umbilical cord graft (UCG) on DFUs. 25 patients were screened for the study, with 15 patients completing the trial. 6/15 (40%) had complete closure prior to or at the study endpoint. Of the patients whose ulcers did not close by Week-12 (9/15 patients, 60%), eight patients had a 50% or greater improvement by Week-12 (88.8%), and five of those ulcers (55.5%) had a closure rate 90% or greater by week 12. Among the entire cohort, fourteen patients (93.3%) had 50% or greater wound reduction by Week-12, and eleven patients (73.3%) patients had 90% or greater wound reduction by Week-12. Only one patient had 2 applications of graft; the remaining 14 had one application only. Further studies need to be designed to compare DMSO vs. Non-DMSO UCG effectiveness in slow-to-heal DFUs. However, based on our findings, non-DMSO viable umbilical cord graft is an effective way to treat challenging DFUs